Impacts of Nicotinamide Riboside on Functional Capacity and Muscle Physiology in Older Veterans

NCT04691986 | Active Not Recruiting DMC

• 2 other identifiers: E3396-RRX003396
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is an age-associated clinical condition of poor physiological reserve that increases risks for falls, hospitalization and mortality. Nicotinamide adenine dinucleotide (NAD) is a critical co-factor needed for many cellular processes. The natural levels of NAD decline aging and this has been linked to physical performance decline in animals. Human trials have demonstrated that nicotinamide riboside (NR), a form of vitamin B3, is safe and effectively increases NAD+ levels. In animal studies, NR improves treadmill performance and muscle quality. Here the investigators propose a double-blind randomized control trial to assess the benefits of NR supplementation on human muscle function and physiology. The investigators anticipate the research findings will support the use of this nutritional supplement to improve the health of Veterans during aging.

Conditions

Nicotinamide Adenine Dinucleotide Concentration; Muscle Quality and NAD+ Content; Sarcopenia

Keywords

muscle; strength; endurance; gait speed; grip strength; frailty; muscle fibers; mitochondria; inflammation; resilience; aging

Outcome Measures

Primary Outcomes (3)

• Sub-maximal oxygen uptake test (VO2max)

  Participants are asked to exercise on an recumbent exercise bike as the resistance increases over time. During the exercise, participants are asked to breath through a mask that is connected to a oxygen and carbon dioxide measuring device. Participant will be asked to continue until they report exhaustion, reach 85% of heart rate maximum, or if there are medical concerns. The assessment last for approximately 15 minutes and provides data the pertain to an individuals lung capacity, breathing rate, and endurance.

  Change from baseline to endpoint at 12 weeks

• Muscle strength

  Leg and arm strength will be measured using a small handheld dynamometer where the device is placed on the wrist or ankle as the participant is asked to extend or contract the limb with full force.

  Change from baseline to endpoint at 12 weeks

• Gait speed

  Participants are asked to perform a timed walk of approximately 15 feet in length

  Change from baseline to endpoint at 12 weeks

Secondary Outcomes (9)

• Frailty assessment

  Change from baseline to endpoint at 12 weeks

• Short Physical Performance Battery

  Change from baseline to endpoint at 12 weeks

• Quality of life assessment

  Change from baseline to endpoint at 12 weeks

• Cognitive screen

  Change from baseline to endpoint at 12 weeks

• Serum inflammatory biomarkers

  Change from baseline to endpoint at 12 weeks

Study Arms (2)

NR Supplementation

EXPERIMENTAL

Participants in this group will receive NR supplementation at 1000 mg per day (given as 2x250mg capsules morning and 2x250mg at night).

Dietary Supplement: Nicotinamide Riboside

Placebo supplementation

PLACEBO COMPARATOR

Participants in this group will receive placebo given as 2 pills in the morning and 2 pills at night. Placebo pills contain micro cellulose which is likewise found in NR containing capsules.

Other: Placebo

Interventions

Nicotinamide Riboside DIETARY_SUPPLEMENT

Nicotinamide Riboside is a form of vitamin B3 and is naturally occurring in humans.

Also known as: NR

NR Supplementation

Placebo OTHER

Placebo pills contain micro cellulose powder.

Placebo supplementation

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Ages 65-85
• Male or female
• Any race
• Ability to use an exercise bike
• Medically cleared for muscle biopsy

You may not qualify if:

• Severe Co-morbidity
• examples include, but not limited to:
• congestive heart failure class equal to or above III
• chronic obstructive pulmonary disorder (COPD) gold stage IV
• chronic kidney disease equal to or above stage
• A VA-SLUMS cognitive screen score of less than or equal to 20
• Body mass index greater than or equal to 40

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University at Buffalo: collaborator

Study Sites (1)

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, 64128-2226, United States

Location

MeSH Terms

Conditions

Sarcopenia; Frailty; Inflammation

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Kenneth L Seldeen, PhD

  Kansas City VA Medical Center, Kansas City, MO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study design participants, care providers, and investigators will be blinded to the group designation of the participants. To accomplish this, the study statistician will coordinate with the VA pharmacy to assign groups to participants and to dispense appropriate treatments to the study coordinator to give to study participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study will be conducted as a double-blind randomized controlled trial. Participants will be randomly assorted to receive either the nicotinamide riboside supplementation or a placebo pill.

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 31, 2020
• Study Start: September 1, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: individual participant data that is used in publication and/or presentations/seminars may become available during the study or immediately thereafter depending on if the data sufficiently merits dissemination. De-identified raw data associated with a publication, if made accessible, will be made available at the time of publication, otherwise, if not associated with a publication, will be made available at the conclusion of the study (06/30/2026).
• Access Criteria: De-identified study data that does not containing protected health information (PHI) will be made accessible upon approval of the study team. Written request should be sent to the principal investigator.

Locations

US (1)